1. Field of the Invention
The present invention relates to an ostomy appliance, an ostomy sealing member and to methods for placing an ostomy appliance on the abdomen of an ostomate.
In connection with surgery for a number of diseases in the gastro-intestinal tract a consequence is, in many cases, that the colon, the ileum or the urethra has been exposed surgically and the patient is left with an abdominal stoma and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag, which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accommodating the stoma. Also in connection with a fistula, the patient will have to rely on an appliance to collect the bodily material emerging from such opening.
Ostomy appliances are well known. Such appliances may be two-piece or one-piece appliances. In both types of appliances, a body side member is attached to the wearer""s abdomen, and, in case of a two-piece appliance, a receiving member or bag is releasably attached to the body side ostomy member for receiving exudates from the stoma.
When using one-piece appliances, the whole appliance, including the adhesive wafer or pad securing the appliance to the skin is removed and replaced by a fresh appliance. When using two-piece appliances, the body side ostomy member is left in place for several days, and only the receiving member or bag is replaced.
The production of ostomy products with a flat proximal adhesive side includes producing a plane disc of adhesive suitable for use on the human skin which is typically provided with a carrier sheet on one side (the distal) and a release liner on the other. The carrier sheet on the distal side of the adhesive is attached, e.g. by gluing or welding, to a collection bag or to a coupling part, to which a collection bag may be detachably coupled. The release liner on the proximal side of the adhesive is a protective sheet, which is removed prior to use, and the ostomy appliance is then adhered to the user""s skin by means of the substantially plane proximal side of the adhesive.
The service time of the body side ostomy member depends on the amount and aggressiveness of the exudates and of the tightness of the sealing between the stoma and the body side ostomy member.
In the known appliances it is necessary to change the body side member of a two-piece appliance when the centre part of the adhesive wafer or pad has been sufficiently deteriorated to allow access of the aggressive exudates to the skin surrounding the stoma, irrespective of the fact that the wafer as such has a much longer wearing time. The access of aggressive exudates to the skin is causing skin problems.
At the same time, it is often difficult to obtain a reliable sealing between the adhesive wafer and the stoma in order to prevent the aggressive exudates from contacting the skin.
2. Description of the Related Art
Methods of overcoming the sealing problems have been proposed.
GB Patent Application No. GB 2 290 974 discloses a body-side ostomy member comprising a ring to which a bag-side coupling ring or a bag can be attached, said ring comprising a rib and a flange, said flange being mounted on a wafer of medical grade adhesive having a central whole of diameter at least 65% of the internal diameter of the ring. When applying such body-side ostomy member, a mouldable mass of non-hypoallergenic, non-memory putty-like adhesive, particularly based on hydrocolloid or hydrogel, is disposed radially inward of the wafer so that it forms a protective mass surrounding the stoma. The mouldable mass has a thickness of 1.25-3 times that of the wafer and a central hole therein of a diameter no more than 1/10 th of the internal diameter of the ring. Both the medical grade adhesive and the mouldable adhesive are adhered to the skin.
European Patent application No. EP 0 686 381 discloses an ostomy appliance comprising a collection pouch and faceplate assembly including a flexible patch having a stoma-receiving opening, a first layer of skin-friendly hydrocolloid-containing adhesive material along one side of said patch about said opening for securing said faceplate assembly to peristomal skin surfaces, and a second layer of relatively soft, easily deformable and extrudable, adhesive sealant material of a composition that is resistant to being dissolved or disintegrated by stomal fluids and that immediately surrounds said opening; said second layer being displaceable inwardly and axially into said opening for forming a stoma-engaging annular gasket to prevent stomal fluids from contacting the peristomal skin and said first adhesive layer.
These references, however, do not address the problem that the appliance as a whole must be replaced and thus, the remaining life-time of the part of the adhesive wafer securing the appliance to the abdomen of the ostomate is not utilised and the skin is exposed to an undesirable stress due to many exchanges of the appliance.
In ostomy patients it is frequently seen that the immediate surroundings of the stoma, at a distance of 1-2 cm, are recessed or are positioned in a crater or a cavity as compared to the rest of the skin surface surrounding the stoma. For such patients it has been found to be expedient to use an ostomy product where the adhesive surface around the opening for receiving the stoma has a part which is convex and protrudes toward the user in order to enable the adhesive face of the ostomy appliance to contact and adhere to essentially the entire surface of the skin in the crater or the cavity. In particular, it is important that the ostomy appliance adheres well to the skin in the area next to the stoma in order to give security against deterioration of the adhesive and against leakage. The use of an adhesive wafer having a rigid convex shape may also apply an external pressure to the area next to the stoma which, in particularly in connection with recessed stomas, will ensure a sufficient protrusion of the stoma to aid the discharge of effluents therefrom directly into the collection bag without contacting the exposed adhesive next to the stoma and prolong the time of service of the adhesive wafer or plate. The shape of the protruding part of the adhesive face may e.g. be domed or conical, and such products are known under the designation convex products.
EP 317 326 describes a convex product having a rigid ring carrying on its entire convex side an intermediate ring of a soft thermoplastic foam material adhered to the rigid ring.
European Patent Application and EP 416 397 describes convex products where a layer of adhesive suitable for use on the human skin is arranged directly on the convex face of a ring-shaped body.
U.S. Pat. No. 5,618,276 discloses an ostomy appliance in which a thermoplastic convex pressure ring also functions as a belt attachment ring. The pressure ring is directly and sealingly secured on its convex side to an adhesive faceplate and it is also directly and sealingly secured on its opposite side to a collection pouch.
WO 95/24169 discloses an ostomy appliance comprising a ring-shaped body having a convex proximal side and a distal side as well as an inner periphery and an outer periphery, a layer of adhesive to attach the ring-shaped body to a user""s skin with the proximal side facing the user""s skin, which adhesive is present on a thermoplastic carrier sheet having at least the same extent as the adhesive, and wherein the carrier sheet is disposed between the adhesive and the ring-shaped body and is attached to the proximal side of the ring-shaped body along the inner periphery and the outer periphery thereof with mutual spaces.
EP 0 894 482 discloses an ostomy appliance comprising a ring-shaped body having a convex proximal side and a distal side as well as an inner periphery and an outer periphery, a layer of adhesive to attach the ring-shaped body to a user""s skin with the proximal side facing the user""s skin, said adhesive being present on a thermoplastic carrier sheet having at least the same extent as the adhesive, disposed between the adhesive and the ring-shaped body wherein the carrier sheet is attached to the proximal side of the ring-shaped body along the outer periphery thereof and optionally along the inner periphery and wherein a further adhesive layer is present in the area between the inner and outer periphery.
None of these references address the problem of providing a seal between the adhesive plate of the appliance and the ostomy for preventing skin problems due to contact between the bodily material emerging from the stoma and the skin surrounding the same.
WO 98/17212 discloses an ostomy appliance comprising a body side member comprising an adhesive wafer or pad for securing the appliance to the user""s skin, said wafer or pad having a hole for receiving a stoma, and an optionally separately exchangeable receiving member or bag secured to the body side ostomy member for receiving secretions from the stoma said ostomy appliance further comprising a separate sealing member disposed in the hole of the wafer or pad surrounding the stoma.
Furthermore, there is often a problem in that, due to a retracted stoma in which case is often used a convex product or in case of skin problems or folds or other irregularities, it may be difficult to place the body side member centrally with respect to the stoma. The result is that the stoma is often situated shifted with respect to the centre of the hole in the adhesive wafer for accommodating the stoma. In such cases it is especially difficult to obtain a reliable sealing between the adhesive plate of the appliance and the ostomy. No solution to this problem is offered or indicated in the above references.
It has been found that all the above problems may be overcome using the solution provided with the present invention.
The invention relates to an ostomy appliance comprising a body side member, an optionally separately exchangeable receiving member or bag secured to the body side member, said body side member comprising a ring-shaped body having an adhesive wafer having a hole for accommodating a stoma and further a separate sealing member which, when in use, is placed in the hole for sealing against the stoma, wherein the separate sealing member has a hole for accommodating the stoma and comprises a mouldable mass of a hypo-allergenic, substantially non-memory putty-like adhesive is in the form of a disc, wherein the disc has an outer diameter smaller than the diameter of the hole of the wafer or pad of the ostomy body side member, wherein the disc has a flange member stretching from its outer rim, and wherein the flange has outer dimensions greater than the diameter of the hole of the body side member for coupling to the body side member.
Furthermore, the invention relates to an ostomy sealing member in the form of a mouldable mass of a hypo-allergenic, substantially non-memory putty-like adhesive in the form of a disc, said disc having a hole for accommodating a stoma, and said disc having a flange member stretching from its outer rim.
Still further, the invention relates to methods for placing an ostomy appliance on the abdomen of an ostomate around a stoma or fistula for collecting bodily material emerging from such opening, in which an ostomy appliance comprising a body side member, an optionally separately exchangeable receiving member or bag secured to the body side member, said body side member comprising a ring-shaped body having an adhesive wafer having a hole for accommodating the stoma and further a separate sealing member which, in use, is placed in the hole for sealing against the stoma.